Uk Mhra Gmp
ROCHE CAROLINAROCHE CAROLINA – UK MHRA GMP Certificate UK API 18788 Insp GMP 18788/11325-0002 [V]
Record Details
This Uk Mhra Gmp record concerns ROCHE CAROLINA, with an inspection on January 27, 2014, issued by the MHRA, covering veterinary.
- Company
- ROCHE CAROLINA
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- January 27, 2014
- Issued
- April 10, 2014
- MIA number
- UK API 18788
- Site address
- INCORPORATED, 6173 EAST OLD MARION HIGHWAY, FLORENCE, 29506-9330, UNITED STATES
- Country
- UNITED STATES
- Products
- Veterinary Medicinal Products
- Manufacturing operations
- [1000011433] CAPECITABINE [2000006801] OSELTAMIVIR PHOSPHATE [1000002752] ORLISTAT [2000006980] VALGANCICLOVIR HYDROCHLORIDE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES CAPECITABINE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing OSELTAMIVIR PHOSPHATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Delumping using a comil 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing ORLISTAT 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Milling 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing VALGANCICLOVIR HYDROCHLORIDE 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing
- Restrictions
- Excludes the Development/Pilot Plan Building 800
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ID · 7ba7c430-0f3e-4804-81bb-c25a37dae98f
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